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Trial · NCT01170117

Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

NCT01170117, Not applicable, Completed, New York State Psychiatric Institute; results first posted 2017-08-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa. Trials, record NCT01170117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01170117

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
NCT number
NCT01170117
Status
Completed
Phases
Not applicable
Enrollment
152 participants, actual
Lead sponsor
New York State Psychiatric Institute
Conditions
Anorexia Nervosa
Interventions
Olanzapine, Placebo
First posted
2010-07-27
Last updated
2018-06-29
Results first posted
2017-08-25

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of Weight ChangeWeekly during 16-week trial and twice during 8 weeks follow-upComparison of rate of weight change between patients receiving olanzapine and those receiving placebo
PrimaryPsychological ChangeWeekly during 16-week intervention and twice during 8-week follow-up
Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYRate of Weight ChangeWeekly during 16-week trial and twice during 8 weeks follow-upPatients assigned to receive placebo or olanzapine for 16 weeks.kg/m^2 per monthMEAN
PRIMARYPsychological ChangeWeekly during 16-week intervention and twice during 8-week follow-upYBOCs score units per monthMEAN

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Rate of Weight ChangePlacebo0.095Standard Error 0.053kg/m^2 per month
Rate of Weight ChangeOlanzapine0.260Standard Error 0.051kg/m^2 per month
Psychological ChangePlacebo0.762Standard Deviation 0.375YBOCs score units per month
Psychological ChangeOlanzapine0.800Standard Deviation 0.350YBOCs score units per month

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPlacebo77
Overall StudySTARTEDOlanzapine75
Overall StudyCOMPLETEDPlacebo47
Overall StudyCOMPLETEDOlanzapine55
Overall StudyNOT COMPLETEDPlacebo30
Overall StudyNOT COMPLETEDOlanzapine20

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherMild undulating movement in his posterior tongue on the Abnormal Involuntary Movement ScaleMusculoskeletal and connective tissue disordersPlacebo0770
otherMild undulating movement in his posterior tongue on the Abnormal Involuntary Movement ScaleMusculoskeletal and connective tissue disordersOlanzapine1751
otherRashSkin and subcutaneous tissue disordersPlacebo0770
otherRashSkin and subcutaneous tissue disordersOlanzapine1751
seriousPatient hospitalized in eating disorder center to pursue higher level of care.Psychiatric disordersPlacebo7777
seriousPatient hospitalized in eating disorder center to pursue higher level of care.Psychiatric disordersOlanzapine117511
seriousOverdoseInjury, poisoning and procedural complicationsPlacebo0770
seriousOverdoseInjury, poisoning and procedural complicationsOlanzapine2752
seriousAbnormal EKGCardiac disordersPlacebo1771
seriousAbnormal EKGCardiac disordersOlanzapine1751

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo077
Total, all-cause mortalityOlanzapine075
Total, other adverse eventsPlacebo077
Total, other adverse eventsOlanzapine275
Total, serious adverse eventsPlacebo1377
Total, serious adverse eventsOlanzapine1675

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
18558642BACKGROUNDPubMed
30654643DERIVEDPubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01MH085921Olanzapine Versus Placebo in Outpatients with Anorexia NervosaATTIA, EVELYNNEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INCNATIONAL INSTITUTE OF MENTAL HEALTH2010 to 2014

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Olanzapine vs Placebo: deaths from any causeTrial comparisons
Olanzapine vs Placebo: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01170117

GET https://conductscience.org/api/trials/v1/NCT01170117/registered